[Federal Register Volume 84, Number 129 (Friday, July 5, 2019)]
[Rules and Regulations]
[Pages 32088-32094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14325]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0186; FRL-9994-37]
Indoxacarb; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of indoxacarb in or on grass forage and grass hay. This action
is in response to EPA's granting of an emergency exemption under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing
use of the pesticide on mixed stands of alfalfa and grasses. Tolerances
are already established for residues of indoxacarb in/on alfalfa forage
and alfalfa hay and this regulation establishes maximum permissible
levels for residues of indoxacarb in or on grass forage and grass hay.
The time-limited tolerances expire on December 31, 2022.
DATES: This regulation is effective July 5, 2019. Objections and
requests for hearings must be received on or before September 3, 2019
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0186, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect
of this regulation and may also request a hearing on those objections.
You must file your objection or request a hearing on this regulation in
accordance with the instructions
[[Page 32089]]
provided in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number EPA-HQ-OPP-2019-0186 in the subject line on
the first page of your submission. All objections and requests for a
hearing must be in writing and must be received by the Hearing Clerk on
or before September 3, 2019. Addresses for mail and hand delivery of
objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2019-0186, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-EPA-dockets.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with FFDCA sections
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is
establishing time-limited tolerances for residues of indoxacarb, (S)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, in/on grass, forage at 10
parts per million (ppm) and in/on grass, hay at 50 ppm. These time-
limited tolerances expire on December 31, 2022.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under FIFRA
section 18. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18 related time-limited tolerances to set binding
precedents for the application of FFDCA section 408 and the safety
standard to other tolerances and exemptions. Section 408(e) of FFDCA
allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative, i.e., without having
received any petition from an outside party.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Indoxacarb in Mixed Stands of Alfalfa and
Grasses and FFDCA Tolerances
The California Department of Pesticide Regulations (CDPR) notified
EPA that an emergency condition exists with respect to control of
alfalfa weevils in mixed stands of alfalfa and grasses in the
Intermountain Region of California. According to CDPR, an urgent and
nonroutine situation arose due to the weevils' developing resistance to
the commonly relied-upon pyrethroids, and without a suitable pesticide
control, significant losses were expected due to yield and quality
decreases. Indoxacarb is registered for use in alfalfa but not for
grasses and thus there was a need for an emergency exemption for use in
mixed stands of alfalfa and grasses. After having reviewed the
submission, EPA determined that an emergency condition exists for this
State, and that the criteria for approval of an emergency exemption are
met. EPA has authorized a specific exemption under FIFRA section 18 for
the use of indoxacarb on mixed stands of alfalfa and grasses for
control of alfalfa weevils in California.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of indoxacarb in
or on grass, forage and grass, hay. In doing so, EPA considered the
safety standard in FFDCA section 408(b)(2) and decided that the
necessary tolerance under FFDCA section 408(l)(6) would be consistent
with the safety standard and with FIFRA section 18. Consistent with the
need to move quickly on the emergency exemption to address an urgent
and non-routine situation and to ensure that the resulting food is safe
and lawful, EPA is issuing these tolerances without notice and
opportunity for public comment as provided in FFDCA section 408(l)(6).
Although these time-limited tolerances expire on December 31, 2022,
under FFDCA section 408(l)(5), residues of the pesticide not in excess
of the amounts specified in the tolerances remaining in or on grass,
forage and grass, hay after that date will not be unlawful, provided
the pesticide was applied in a manner that was lawful under FIFRA, and
the residues do not exceed the levels that were authorized by these
time-limited tolerances at the time of that application. EPA will take
action to revoke these time-limited tolerances earlier if any
experience with, scientific data on, or other relevant information on
this pesticide indicate that the residues are not safe.
Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
indoxacarb meets FIFRA's registration requirements for use on grasses
or whether permanent tolerances for this use would be appropriate.
Under these circumstances, EPA does not believe that these time-limited
tolerance decisions serve as bases for registration of indoxacarb by a
State for special local needs under FIFRA section 24(c). Nor do these
tolerances by themselves serve as authority for persons in any State
other than California to use this pesticide on the applicable crops
under FIFRA
[[Page 32090]]
section 18 absent the issuance of an emergency exemption applicable
within that State. For additional information regarding the emergency
exemption for indoxacarb, contact the Agency's Registration Division at
the address provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with the factors specified in FFDCA section
408(b)(2)(D), EPA has reviewed the available scientific data and other
relevant information in support of this action. EPA has sufficient data
to assess the hazards of and to make a determination on aggregate
exposure expected as a result of this emergency exemption use and the
time-limited tolerances for combined residues of indoxacarb on grass,
forage and grass, hay at 10 ppm and 50 ppm, respectively. There are
existing tolerances for residues of indoxacarb in/on meat and milk
commodities, and EPA has determined that the existing tolerances for
meat and milk commodities will not be exceeded by additional residues
in grass forage and hay. EPA's assessment of exposures and risks
associated with establishing the time-limited tolerances follows.
A. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (PODs) and levels of
concern (LOCs) to use in evaluating the risk posed by human exposure to
the pesticide. For hazards that have a threshold below which there is
no appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose or level at which no adverse effects are observed
(the NOAEL) and the lowest level at which adverse effects of concern
are identified (the LOAEL). Uncertainty/safety factors are used in
conjunction with the POD to calculate a safe exposure level--generally
referred to as a population-adjusted dose (PAD) or a reference dose
(RfD)--and a safe margin of exposure (MOE). For non-threshold risks,
the Agency assumes that any amount of exposure will lead to some degree
of risk. Thus, the Agency estimates risk in terms of the probability of
an occurrence of the adverse effect expected in a lifetime. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for indoxacarb used for
human risk assessment is discussed in Unit III of the final rule
published in the Federal Register of December 8, 2017 (82 FR 57860)
(FRL-9970-39).
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to indoxacarb, EPA considered exposure under the time-limited
tolerances established by this action as well as all existing
indoxacarb tolerances in 40 CFR 180.564. EPA assessed dietary exposures
from indoxacarb in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Acute effects were
identified for indoxacarb. In estimating acute dietary exposure, EPA
used food consumption information from the United States Department of
Agriculture's (USDA's) 2003-2008 National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA). As to
residue levels in food, EPA used full distributions of residue levels
from the results of field trials reflecting maximum use patterns in all
commodities and used maximum Percent Crop Treated (PCT) estimates.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the EPA used food
consumption information from the USDA's 2003-2008 NHANES/WWEIA. As to
residue levels in food, EPA used average residue levels based on the
results of field trials reflecting maximum use patterns in all
commodities and used average PCT estimates.
iii. Cancer. Based on the data referenced in Unit IV.A., EPA has
concluded that indoxacarb does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for assessing cancer risk is
unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency estimated the maximum and average PCT for the acute and
chronic dietary assessments for existing uses as follows:
For acute dietary assessment: Apples: 10%;
apricots: 15%; blueberries: 5%; broccoli: 70%; cabbage: 35%;
cantaloupe: 10%; cauliflower: 60%; celery: 5%; cherries: 2.5%; cotton:
2.5%; cucumbers: 10%; grapes: 5%; lettuce: 15%; nectarines: 15%;
peaches: 10%; peanuts: 10%; pears: 2.5%; peppers: 30%; plums/prunes:
5%; potatoes: 2.5%; soybeans: 2.5%; spinach: 5%; squash: 5%; sweet
corn: 10%; and tomatoes: 40%.
For chronic dietary assessment: Apples: 5%;
apricots: 5%; blueberries: 5%; broccoli: 45%; cabbage: 20%; cantaloupe:
5%; cauliflower: 35%; celery: 5%; cherries: 2.5%; cotton: 2.5%;
cucumbers: 2.5%; grapes: 2.5%; lettuce: 5%; nectarines: 15%; peaches:
2.5%; peanuts: 5%; pears: 1%; peppers: 15%; plums/prunes: 5%; potatoes:
2.5%; soybeans: 1%; spinach: 2.5%; squash: 2.5%; sweet corn: 2.5%; and
tomatoes: 20%.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most
[[Page 32091]]
recent 6 to 7 years. EPA uses an average PCT for chronic dietary risk
analysis. The average PCT figure for each existing use is derived by
combining available public and private market survey data for that use,
averaging across all observations, and rounding to the nearest 5%,
except for those situations in which the average PCT is less than 2.5%.
In those cases, estimates of average PCT between 1% and 2.5% are
rounded to 2.5% and estimates of average PCT less than 1% are rounded
to 1%. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%,
except for those situations in which the maximum PCT is less than 2.5%.
In those cases, EPA uses a maximum PCT value of 2.5%.
The Agency believes that the three conditions discussed in Unit
IV.B.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which indoxacarb may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for indoxacarb in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of indoxacarb. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Surface Water Concentration Calculator (SWCC) model
and the Pesticide Root Zone Model Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of indoxacarb for acute exposures
are estimated to be 39 parts per billion (ppb) for surface water and
131 ppb for ground water; for chronic exposures the EDWCs are 11 ppb
for surface water and 123 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, a time series distribution of ground water modeled residues
was used to assess the contribution to drinking water. For chronic
dietary risk assessment, a single point water concentration value of
123 ppb was used to assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Indoxacarb is currently registered for the following uses that
could result in residential exposures: Pet spot-on uses, spot and crack
and crevice applications indoors, outdoor broadcast (i.e., turf),
perimeter and foundations, spot outdoors (i.e., direct mound
applications for fire ants), and crack and crevice outdoors. Based on
these use scenarios, EPA assessed residential exposure using the
following assumptions:
Spot and crack and crevice exposures were not
quantified due to formulation types that minimize the potential for
handler and postapplication exposures (i.e., gels or bait stations).
Risks from spot and crack and crevice were not quantified because
exposures from these formulation types are expected to be negligible.
Residential handler exposure: There is a
potential for dermal and inhalation exposure. Residential handler
inhalation exposure is considered negligible for applying ready-to-use
pet spot-ons. Residential handler dermal exposures are expected for
ready-to-use pet spot-ons, however dermal exposures were not quantified
due to the lack of a dermal endpoint. Residential handler inhalation
and dermal exposures are considered negligible for applying ready-to-
use materials (i.e., baits or stations).
Residential post-application dermal and
incidental oral exposure: Postapplication assessments were not
conducted for ant mound uses, because these are considered perimeter/
spot uses; residential exposure is expected to be negligible. Spot and
crack and crevice exposures were not quantified for gels or bait
stations; exposure is considered negligible. A golfer assessment was
not conducted, due to the lack of a dermal endpoint. Postapplication
inhalation exposure is generally not assessed following application to
pets and turf. The combination of low vapor pressure (1.9 x
10-10 mm Hg at 25 [deg]C for indoxacarb) of active
ingredients typically used in pet and turf pesticide products, and the
small amounts of pesticide applied to pets is expected to result in
only negligible inhalation exposure. Ingestion of granules is
considered an episodic event and not a routine behavior. Because the
Agency does not expect this to occur on a regular basis, concern for
human health is related to acute poisoning rather than short-term
residue exposure. For these reasons, the episodic ingestion scenario is
not included in the aggregate assessment. The only route of residential
exposure for inclusion in the adult aggregate assessment is inhalation.
However, for adults it would be inappropriate to aggregate inhalation
exposures with background dietary exposures because the toxicity
endpoints for the inhalation and short-term oral routes are different.
Therefore, the only residential exposures that were combined are for
children 1 to <2 years old in the short-term aggregate assessment that
reflects hand-to-mouth exposures from post-application exposure to spot
treatment on carpets, and children 1 to <2 years old in the
intermediate- and long-term aggregate assessment that reflects
exposures from treated pets.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at: https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found indoxacarb to share a common mechanism of
toxicity with any other substances, and
[[Page 32092]]
indoxacarb does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that indoxacarb does not have a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's website at
https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
C. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional SF when reliable data
available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. There was no evidence of
reproductive effects in rats. There was no evidence of increased
susceptibility in developing fetuses or in the offspring following
prenatal and/or postnatal exposure to indoxacarb in rats or rabbits.
There was no evidence of increased susceptibility in the young in the
developmental neurotoxicity study in rats.
3. Conclusion. EPA has determined that reliable data show that the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for indoxacarb is complete.
ii. The acute neurotoxicity, subchronic toxicity, and developmental
neurotoxicity studies for indoxacarb are available and all endpoints
used in the risk assessment are protective of neurotoxic effects.
iii. There is no evidence that indoxacarb results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases.
The Agency estimated maximum and average PCT values for the acute
and chronic dietary assessments, as shown in unit IV.B.1.iv. Food
residues were taken from the results of supervised field trial studies
reflecting maximum use patterns. Drinking water residues were included
in the dietary assessments as follows: A point estimate of 123 ppb was
used for the chronic assessment and the time series distribution of
ground water modeled residues was used in the acute assessment as a
residue distribution file in the Monte Carlo analysis. For food
commodities, Residue Distribution Files (RDFs) were constructed for the
probabilistic acute dietary assessment as appropriate, and average
residues were used for blended commodities. For the chronic dietary
assessment, either average residue levels from field trial studies were
used or for crops where no residues were found, a value of \1/2\ the
limit of quantitation was assumed. EPA used similarly conservative
assumptions to assess post-application exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by indoxacarb.
D. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that
adequate MOEs exist.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to indoxacarb will occupy 56% of the aPAD for children ages 1-2, the
population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
indoxacarb from food and water will utilize 35% of the cPAD for all
infants <1 year old, the population group receiving the greatest
exposure. EPA has concluded the combined long-term food, water, and
residential exposures result in an aggregate MOE of 260 (food, water,
and residential) for children aged 1-2. Because EPA's level of concern
for indoxacarb is an MOE of 100 or below, this MOE is not of concern.
For adults, residential inhalation exposures cannot be aggregated
because they are based on different effects than for oral exposures.
Therefore, long-term aggregate risk for adults is equivalent to the
chronic dietary risk noted in this unit.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Indoxacarb is
currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure to children aged 1-2 years
through food and water with short-term residential exposures to
indoxacarb. For adults, residential inhalation exposures cannot be
aggregated with chronic dietary because they are based on different
effects than for oral exposures. Because chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess short-term risk) and
inhalation risk has been assessed for adults, no further assessment of
short-term risk is necessary for adults, and EPA relies on the findings
from the chronic dietary risk assessment and inhalation assessment, as
noted in unit IV.D.2 and IV.D.3, for evaluating short-term risk to
adults for indoxacarb.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 120 (food, water,
and residential) for children aged 1-2. Because EPA's level of concern
for indoxacarb is an MOE of 100 or below, this MOE is not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Indoxacarb is currently registered for uses that could result
in intermediate-term residential exposure, and the Agency has
determined that it is appropriate to aggregate chronic exposure to
children ages 1-2 years through food and water with intermediate-term
residential exposures to indoxacarb. For adults, residential inhalation
exposures cannot be aggregated with chronic dietary because they are
based on different effects than for oral exposures. Because chronic
dietary exposure has already been assessed under the appropriately
protective cPAD (which is at least as protective as the POD used to
assess
[[Page 32093]]
intermediate-term risk), no further assessment of intermediate-term
risk is necessary for adults, and EPA relies on the findings from the
chronic dietary risk assessment, as noted in unit IV.D.2, for
evaluating intermediate-term risk to adults for indoxacarb.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures for children
aged 1-2 years result in an aggregate MOE of 260. Because EPA's level
of concern for indoxacarb is an MOE of 100 or below, this MOE is not of
concern.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, indoxacarb is not expected to pose a cancer risk to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children, from aggregate
exposure to indoxacarb residues.
V. Other Considerations
A. Analytical Enforcement Methodology
For the enforcement of tolerances established on crops, two High
Performance Liquid Chromatograph/Ultraviolet Detection (HPLC/UV)
methods, DuPont protocols AMR 2712-93 and DuPont-11978, are available
for use. The limits of quantitation (LOQs) for these methods range from
0.01 to 0.05 ppm for a variety of plant commodities. A third procedure,
Gas Chromatograph/Mass-Selective Detection (GC/MSD), DuPont method AMR
3493-95 Supplement No. 4, is also available for the confirmation of
residues in plants.
The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established MRLs for indoxacarb in/on grass
forage or grass hay.
VI. Conclusion
Therefore, time-limited tolerances are established for residues of
indoxacarb, (S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, in or on grass, forage at 10
ppm and grass, hay at 50 ppm. These tolerances expire on 12/31/2022.
VII. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA sections 408(e) and
408(l)(6). The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993).
Because this action has been exempted from review under Executive Order
12866, this action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive
Order 13045, entitled ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This
action does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
Since tolerances and exemptions that are established in accordance
with FFDCA sections 408(e) and 408(l)(6), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 28, 2019.
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
[[Page 32094]]
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.564, add paragraph (b) to read as follows:
Sec. 180.564 Indoxacarb; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for residues of the
indoxacarb, including its metabolites and degradates, in or on the
specified agricultural commodities in the table below, resulting from
use of the pesticide pursuant to FIFRA section 18 emergency exemptions.
Compliance with the tolerance levels specified in the table below is to
be determined by measuring only indoxacarb, (S)-methyl 7-chloro-2,5-
dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate.
The tolerances expire on the dates specified in the table.
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
------------------------------------------------------------------------
Grass, forage................................. 10 12/31/2022
Grass, hay.................................... 50 12/31/2022
------------------------------------------------------------------------
* * * * *
[FR Doc. 2019-14325 Filed 7-3-19; 8:45 am]
BILLING CODE 6560-50-P